Remote diagnostics of respiratory therapy devices

ABSTRACT

A system and method is disclosed for performing diagnostics on patient devices ( 720 ). The patient devices ( 720 ) may include respiratory therapy devices that operate in accordance with instruction sets, such as software or firmware. A server ( 710 ) may maintain a database of diagnostic data ( 718 ) indicating faults in one or more of a plurality of patient devices ( 720 ). The server ( 710 ) may transmit this diagnostic data ( 718 ) to one or more computing devices ( 760 ), including identification of faults that have occurred. The server ( 710 ) may also transmit service data to the plurality of patient devices ( 720 ) in order to address the identified faults.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application claims the benefit of the filing date ofAustralian Provisional Application No. 2014901997, filed on May 27,2014, the disclosure of which is hereby incorporated herein byreference.

1 BACKGROUND

1.1 (1) Field of the Technology

The present technology relates to medical devices that may be used inconnection with the detection, diagnosis, treatment, prevention andamelioration of respiratory-related disorders.

1.2 (2) Description of the Related Art

1.2.1 Human Respiratory System and its Disorders

The respiratory system of the body facilitates gas exchange. The noseand mouth form the entrance to the airways of a patient.

The airways include a series of branching tubes, which become narrower,shorter and more numerous as they penetrate deeper into the lung. Theprime function of the lung is gas exchange, allowing oxygen to move fromthe air into the venous blood and carbon dioxide to move out. Thetrachea divides into right and left main bronchi, which further divideeventually into terminal bronchioles. The bronchi make up the conductingairways, and do not take part in gas exchange. Further divisions of theairways lead to the respiratory bronchioles, and eventually to thealveoli. The alveolated region of the lung is where the gas exchangetakes place, and is referred to as the respiratory zone. See“Respiratory Physiology”, by John B. West, Lippincott Williams &Wilkins, 9th edition published 2011.

A range of respiratory disorders exist. Some examples of respiratorydisorders include: Obstructive Sleep Apnea (OSA), Cheyne StokesRespiration (CSR), Obesity Hyperventilation Syndrome (OHS), ChronicObstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) orchest wall disorders.

Otherwise healthy individuals may take advantage of systems and devicesto prevent respiratory disorders from arising.

1.2.2 Therapy

Nasal Continuous Positive Airway Pressure (CPAP) therapy has been usedto treat Obstructive Sleep Apnea (OSA). The hypothesis is thatcontinuous positive airway pressure acts as a pneumatic splint and mayprevent upper airway occlusion by pushing the soft palate and tongueforward and away from the posterior oropharyngeal wall.

Non-invasive ventilation (NIV) provides ventilator support to a patientthrough the upper airways to assist the patient in taking a full breathand/or maintain adequate oxygen levels in the body by doing some or allof the work of breathing. The ventilator support is provided via apatient interface. NIV has been used to treat CSR, OHS, COPD, MD andChest Wall disorders.

Invasive ventilation (IV) provides ventilatory support to patients thatare no longer able to effectively breathe themselves and is providedusing a tracheostomy tube.

Ventilators may control the timing and pressure of breaths pumped intothe patient and monitor the breaths taken by the patient. The methods ofcontrol and monitoring patients typically include volume-cycled andpressure-cycled methods. The volume-cycled methods may include amongothers, Pressure-Regulated Volume Control (PRVC), Volume Ventilation(VV), and Volume Controlled Continuous Mandatory Ventilation (VC-CMV)techniques. The pressure-cycled methods may involve, among others,Assist Control (AC), Synchronized Intermittent Mandatory Ventilation(SIMV), Controlled Mechanical Ventilation (CMV), Pressure SupportVentilation (PSV), Continuous Positive Airway Pressure (CPAP), orPositive End Expiratory Pressure (PEEP) techniques.

1.2.3 Systems

A treatment system may comprise a Respiratory Pressure Therapy Device(RPT device), an air circuit, a humidifier, a patient interface, anddata management.

1.2.4 Patient Interface

A patient interface may be used to interface respiratory equipment toits user, for example by providing a flow of breathable gas. The flow ofbreathable gas may be provided via a mask to the nose and/or mouth, atube to the mouth or a tracheostomy tube to the trachea of the user.Depending upon the therapy to be applied, the patient interface may forma seal, e.g. with a face region of the patient, to facilitate thedelivery of gas at a pressure at sufficient variance with ambientpressure to effect therapy, e.g. a positive pressure of about 10cmH2O.For other forms of therapy, such as the delivery of oxygen, the patientinterface may not include a seal sufficient to facilitate delivery tothe airways of a supply of gas at a positive pressure of about 10cmH2O.

The design of a patient interface presents a number of challenges. Theface has a complex three-dimensional shape. The size and shape of nosesvaries considerably between individuals. Since the head includes bone,cartilage and soft tissue, different regions of the face responddifferently to mechanical forces. The jaw or mandible may move relativeto other bones of the skull. The whole head may move during the courseof a period of respiratory therapy.

As a consequence of these challenges, some masks suffer from being oneor more of obtrusive, aesthetically undesirable, costly, poorly fitting,difficult to use and uncomfortable especially when worn for long periodsof time or when a patient is unfamiliar with a system. For example,masks designed solely for aviators, mask designed as part of personalprotection equipment (e.g. filter masks), SCUBA masks or for theadministration of anaesthetics may be tolerable for their originalapplication, but nevertheless be undesirably uncomfortable to be wornfor extended periods of time, e.g. several hours. This is even more soif the mask is to be worn during sleep.

Nasal CPAP therapy is highly effective to treat certain respiratorydisorders, provided patients comply with therapy. If a mask isuncomfortable, or difficult to use a patient may not comply withtherapy. Since it is often recommended that a patient regularly washtheir mask, if a mask is difficult to clean (e.g. difficult to assembleor disassemble), patients may not clean their mask and this may impacton patient compliance.

While a mask for other applications (e.g. aviators) may not be suitablefor use in treating sleep disordered breathing, a mask designed for usein treating sleep disordered breathing may be suitable for otherapplications.

For these reasons, masks for delivery of nasal CPAP during sleep form adistinct field.

1.2.4.1 Seal-Forming Portion

Patient interfaces may include a seal-forming portion. Since it is indirect contact with the patient's face, the shape and configuration ofthe seal-forming portion can have a direct impact the effectiveness andcomfort of the patient interface.

A patient interface may be partly characterised according to the designintent of where the seal-forming portion is to engage with the face inuse. In one form of patient interface, a seal-forming portion maycomprise two sub-portions to engage with respective left and rightnares. In one form of patient interface, a seal-forming portion maycomprise a single element that surrounds both nares in use. Such singleelement may be designed to for example overlay an upper lip region and anasal bridge region of a face. In one form of patient interface aseal-forming portion may comprise an element that surrounds a mouthregion in use, e.g. by forming a seal on a lower lip region of a face.In one form of patient interface, a seal-forming portion may comprise asingle element that surrounds both nares and a mouth region in use.These different types of patient interfaces may be known by a variety ofnames by their manufacturer including nasal masks, full-face masks,nasal pillows, nasal puffs and oro-nasal masks.

A seal-forming portion that may be effective in one region of apatient's face may be in appropriate in another region, e.g. because ofthe different shape, structure, variability and sensitivity regions ofthe patient's face. For example, a seal on swimming goggles thatoverlays a patient's forehead may not be appropriate to use on apatient's nose.

Certain seal-forming portions may be designed for mass manufacture suchthat one design fit and be comfortable and effective for a wide range ofdifferent face shapes and sizes. To the extent to which there is amismatch between the shape of the patient's face, and the seal-formingportion of the mass-manufactured patient interface, one or both mustadapt in order for a seal to form.

One type of seal-forming portion extends around the periphery of thepatient interface, and is intended to seal against the user's face whenforce is applied to the patient interface with the seal-forming portionin confronting engagement with the user's face. The seal-forming portionmay include an air or fluid filled cushion, or a moulded or formedsurface of a resilient seal element made of an elastomer such as arubber. With this type of seal-forming portion, if the fit is notadequate, there will be gaps between the seal-forming portion and theface, and additional force will be required to force the patientinterface against the face in order to achieve a seal.

Another type of seal-forming portion incorporates a flap seal of thinmaterial so positioned about the periphery of the mask so as to providea self-sealing action against the face of the user when positivepressure is applied within the mask Like the previous style of sealforming portion, if the match between the face and the mask is not good,additional force may be required to affect a seal, or the mask may leak.Furthermore, if the shape of the seal-forming portion does not matchthat of the patient, it may crease or buckle in use, giving rise toleaks.

Another type of seal-forming portion may comprise a friction-fitelement, e.g. for insertion into a naris.

Another form of seal-forming portion may use adhesive to affect a seal.Some patients may find it inconvenient to constantly apply and remove anadhesive to their face.

A range of patient interface seal-forming portion technologies aredisclosed in the following patent applications, assigned to ResMedLimited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in the Adam Circuit manufactured byPuritan Bennett. Another nasal pillow, or nasal puff is the subject ofU.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-BennettCorporation.

ResMed Limited has manufactured the following products that incorporatenasal pillows: SWIFT nasal pillows mask, SWIFT II nasal pillows mask,SWIFT LT nasal pillows mask, SWIFT FX nasal pillows mask and LIBERTYfull-face mask. The following patent applications, assigned to ResMedLimited, describe nasal pillows masks: International Patent ApplicationWO2004/073,778 (describing amongst other things aspects of ResMed SWIFTnasal pillows), US Patent Application 2009/0044808 (describing amongstother things aspects of ResMed SWIFT LT nasal pillows); InternationalPatent Applications WO 2005/063,328 and WO 2006/130,903 (describingamongst other things aspects of ResMed LIBERTY full-face mask);International Patent Application WO 2009/052,560 (describing amongstother things aspects of ResMed SWIFT FX nasal pillows).

1.2.4.2 Positioning and Stabilising

A seal-forming portion of a patient interface used for positive airpressure therapy is subject to the corresponding force of the airpressure to disrupt a seal. Thus a variety of techniques have been usedto position the seal-forming portion, and to maintain it in sealingrelation with the appropriate portion of the face.

One technique is the use of adhesives. See for example US Patentpublication US 2010/0000534.

Another technique is the use of one or more straps and stabilisingharnesses. Many such harnesses suffer from being one or more ofill-fitting, bulky, uncomfortable and awkward to use.

1.2.5 Respiratory Pressure Therapy (RPT) Device

One known RPT device used for treating sleep disordered breathing is theS9 Sleep Therapy System, manufactured by ResMed. Another example of anRPT device is a ventilator. Ventilators such as the ResMed Stellar™Series of Adult and Paediatric Ventilators may provide support forinvasive and non-invasive non-dependent ventilation for a range ofpatients for treating a number of conditions such as but not limited toNMD, OHS and COPD. RPT devices have also been known as flow generators.

The ResMed Elisée™ 150 ventilator and ResMed VS III™ ventilator mayprovide support for invasive and non-invasive dependent ventilationsuitable for adult or paediatric patients for treating a number ofconditions. These ventilators provide volumetric and barometricventilation modes with a single or double limb circuit.

RPT devices typically comprise a pressure generator, such as amotor-driven blower or a compressed gas reservoir, and are configured tosupply a flow of air to the airway of a patient. In some cases, the flowof air may be supplied to the airway of the patient at positivepressure. The outlet of the RPT device is connected via an air circuitto a patient interface such as those described above.

RPT devices typically also include an inlet filter, various sensors anda microprocessor-based controller. A blower may include aservo-controlled motor, a volute and an impeller. In some cases a brakefor the motor may be implemented to more rapidly reduce the speed of theblower so as to overcome the inertia of the motor and impeller. Thebraking can permit the blower to more rapidly achieve a lower pressurecondition in time for synchronization with expiration despite theinertia. In some cases the pressure generator may also include a valvecapable of discharging generated air to atmosphere as a means foraltering the pressure delivered to the patient as an alternative tomotor speed control. The sensors measure, amongst other things, motorspeed, mass flow rate and outlet pressure, such as with a pressuretransducer or the like. The controller may include data storage capacitywith or without integrated data retrieval and display functions.

Table of noise output levels of prior devices (one specimen only,measured using test method specified in ISO3744 in CPAP mode at10cmH₂O).

A-weighted sound power Year Device name level dB(A) (approx.) C-SeriesTango 31.9 2007 C-Series Tango with Humidifier 33.1 2007 S8 Escape II30.5 2005 S8 Escape II with H4i Humidifier 31.1 2005 S9 AutoSet 26.52010 S9 AutoSet with H5i Humidifier 28.6 2010

1.2.6 Humidifier

Delivery of a flow of breathable gas without humidification may causedrying of airways. Medical humidifiers are used to increase humidityand/or temperature of the flow of breathable gas in relation to ambientair when required, typically where the patient may be asleep or resting(e.g. at a hospital). As a result, a medical humidifier is preferablysmall for bedside placement, and it is preferably configured to onlyhumidify and/or heat the flow of breathable gas delivered to the patientwithout humidifying and/or heating the patient's surroundings.Room-based systems (e.g. a sauna, an air conditioner, an evaporativecooler), for example, may also humidify air that is breathed in by thepatient, however they would also humidify and/or heat the entire room,which may cause discomfort to the occupants.

The use of a humidifier with a flow generator or RPT device and thepatient interface produces humidified gas that minimizes drying of thenasal mucosa and increases patient airway comfort. In addition, incooler climates warm air applied generally to the face area in and aboutthe patient interface is more comfortable than cold air.

Respiratory humidifiers are available in many forms and may be astandalone device that is coupled to a respiratory apparatus via an aircircuit, is integrated with or configured to be coupled to the relevantrespiratory apparatus. While known passive humidifiers can provide somerelief, generally a heated humidifier may be used to provide sufficienthumidity and temperature to the air so that the patient will becomfortable. Humidifiers typically comprise a water reservoir or tubhaving a capacity of several hundred milliliters (ml), a heating elementfor heating the water in the reservoir, a control to enable the level ofhumidification to be varied, a gas inlet to receive gas from the flowgenerator or RPT device, and a gas outlet adapted to be connected to anair circuit that delivers the humidified gas to the patient interface.

Heated passover humidification is one common form of humidification usedwith a RPT device. In such humidifiers the heating element may beincorporated in a heater plate which sits under, and is in thermalcontact with, the water tub. Thus, heat is transferred from the heaterplate to the water reservoir primarily by conduction. The air flow fromthe RPT device passes over the heated water in the water tub resultingin water vapour being taken up by the air flow. The ResMed H4i™ and H5i™Humidifiers are examples of such heated passover humidifiers that areused in combination with ResMed S8 and S9 CPAP devices respectively.

Other humidifiers may also be used such as a bubble or diffuserhumidifier, a jet humidifier or a wicking humidifier. In a bubble ordiffuser humidifier the air is conducted below the surface of the waterand allowed to bubble back to the top. A jet humidifier produces anaerosol of water and baffles or filters may be used so that theparticles are either removed or evaporated before leaving thehumidifier. A wicking humidifier uses a water absorbing material, suchas sponge or paper, to absorb water by capillary action. The waterabsorbing material is placed within or adjacent at least a portion ofthe air flow path to allow evaporation of the water in the absorbingmaterial to be taken up into the air flow.

An alternative form of humidification is provided by the ResMedHumiCare™ D900 humidifier that uses a CounterStream™ technology thatdirects the air flow over a large surface area in a first directionwhilst supplying heated water to the large surface area in a secondopposite direction. The ResMed HumiCare™ D900 humidifier may be usedwith a range of invasive and non-invasive ventilators.

2 BRIEF SUMMARY OF THE TECHNOLOGY

Aspects of the disclosure provide a computer implemented methodperforming remote diagnostics in connection with a plurality of patientdevices. The method may include receiving and storing diagnostic datafrom a plurality of patient devices, wherein the diagnostic dataidentifies the presence of a fault in connection with at least one ofthe plurality of patient devices. The method may also include receivinga query for a first portion of the diagnostic data for a first patientdevice, and identifying the presence of a fault based on the firstportion of the diagnostic data. In addition, the method may includetransmitting the first portion of the diagnostic data or the identifiedpresence of a fault, in response to the received query, wherein thefirst portion of the diagnostic data identifies the presence of a faultassociated with the first patient device. The method may still furtherinclude receiving identification of service data to be transmitted tothe first patient device, wherein at least a portion of the service dataaddresses one or more identified faults. The identified service data maythen be transmitted to the first patient device.

The method for diagnostic monitoring of medical devices may alsocomprise: receiving, by one or more processors, diagnostic data from aplurality of patient devices, wherein the diagnostic data identifies oneor more faults in connection with at least one of the plurality ofpatient devices; storing, by the one or more processors, the receiveddiagnostic data; identifying, by the one or more processors, thepresence of a fault associated with a first portion of the diagnosticdata; transmitting, by the one or more processors, at least one of thefirst portion of the diagnostic data and an identified fault inconnection with at least one of the plurality of patient devices to aremote computing device; and transmitting, by the one or moreprocessors, service data identified on the basis of at least one of thefirst portion of the diagnostic data and the one or more identifiedfaults, to the at least one of the plurality of patient devices. Themethod may further comprise receiving, in response to transmitting atleast the first portion of the diagnostic data to the remote computingdevice by the one or more processors, identification of the service datato be transmitted to the at least one of the plurality of patientdevices, wherein at least a portion of the service data addresses theone or more identified faults. It should be noted that the expression“indication of the presence of a fault” used throughout the text of thisdisclosure should be considered to also include an indication that afault is likely to occur in a specific device, as well as an indicationthat no fault is currently present in any of the devices.

In accordance with one aspect, the first patient device comprises arespiratory pressure therapy device. In addition, the diagnostic datamay be received based on the occurrence of a triggering event and may becomprised of therapeutic settings of the patient device. The diagnosticdata may also comprise a log of operations and faults that have occurredin connection with the patient device.

The disclosed method may also include receiving an indication from thefirst patient device that the service data was successfully transmittedand updating the diagnostic data to indicate implementation of the firstservice data.

In accordance with one aspect, the presence of a fault may be identifiedbased on one or more components of the first patient device in which afault has occurred. In addition, the query may further include a requestfor diagnostic data for the plurality patient devices, and transmittingthe first portion of the diagnostic data may include transmittingdiagnostic data for the plurality of patient devices.

Another disclosed method may include a patient device that collectsdiagnostic data relating to the operation of the patient device, whereinthe diagnostic data identifies the presence of a fault that has occurredin connection with the patient device. The patient device may alsodetermine whether a triggering event has occurred for which thediagnostic data is to be transmitted over a network. If a triggeringevent has occurred, the patient device may transmit the diagnostic dataover the network. The patient device may also receive service data thataddresses an identified fault and performing one or more operations inaccordance with the received service data.

In accordance with one aspect, the triggering event may be based on aplurality of conditions being met before the diagnostic data istransmitted. The triggering event may also be based on a patient havingfinished using the patient device for a predetermined period of time.The triggering event may also be based on a schedule for whichdiagnostic data is to be transmitted.

The service data may include a first portion and a second portion,wherein a first component of the patient device operates in accordancewith the first portion of the service data and a second componentoperates in accordance with the second portion of the service data. Inaccordance with one aspect, at least a portion of the diagnostic datamay relate to at least one of a patient's apnea index, hypopnea index,and apnea-hypopnea index.

In another aspect, the service data may include a command to adjust oneor more settings of the patient device, and the diagnostic data mayidentify one or more settings of the patient device at a time at whichthe fault occurred. The identified fault may be provided as an icon fordisplay on the remote computing device, and the icon may have a variableappearance that varies based on the type of fault that has occurred. Inaddition, transmitting the identified fault may include providing usageicons for display on the remote computing device, wherein the usageicons indicate an extent to which the patient device was used.

The disclosure also provides for a system that includes a one or morecomputing devices configured to perform the methods described herein.

3 BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

3.1 Treatment Systems

FIG. 1a shows a system in accordance with the present technology. Apatient 1000 wearing a patient interface 3000, in the form of nasalpillows, receives a supply of air at positive pressure from a RPT device4000. Air from the RPT device is humidified in a humidifier 5000, andpasses along an air circuit 4170 to the patient 1000.

FIG. 1b shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal mask, receives a supply of air atpositive pressure from a RPT device 4000. Air from the RPT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

FIG. 1c shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a full-face mask, receives a supply ofair at positive pressure from a RPT device. Air from the RPT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

3.2 Therapy 3.2.1 Respiratory System

FIG. 2a shows an overview of a human respiratory system including thenasal and oral cavities, the larynx, vocal folds, oesophagus, trachea,bronchus, lung, alveolar sacs, heart and diaphragm.

FIG. 2b shows a view of a human upper airway including the nasal cavity,nasal bone, lateral nasal cartilage, greater alar cartilage, nostril,lip superior, lip inferior, larynx, hard palate, soft palate,oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

3.2.2 Facial Anatomy

FIG. 2c is a front view of a face with several features of surfaceanatomy identified including the lip superior, upper vermillion, lowervermillion, lip inferior, mouth width, endocanthion, a nasal ala,nasolabial sulcus and cheilion.

3.3 Patient Interface

FIG. 3a shows an example of a patient interface known in the prior art.

3.4 Respiratory Pressure Therapy (Rpt) Device

FIG. 4a shows a RPT device in accordance with one form of the presenttechnology.

FIG. 4b shows a schematic diagram of the pneumatic circuit of a RPTdevice in accordance with one form of the present technology. Thedirections of upstream and downstream are indicated.

FIG. 4c shows a schematic diagram of the electrical components of a RPTdevice in accordance with one aspect of the present technology.

3.5 Humidifier

FIG. 5a shows a humidifier in accordance with one aspect of the presenttechnology.

3.6 Breathing Waveforms

FIG. 6a shows a model typical breath waveform of a person whilesleeping, the horizontal axis is time, and the vertical axis isrespiratory flow. While the parameter values may vary, a typical breathmay have the following approximate values: tidal volume, Vt, 0.5 L,inhalation time, Ti, 1.6 s, peak inspiratory flow, Qpeak, 0.4 L/s,exhalation time, Te, 2.4 s, peak expiratory flow, Qpeak, —0.5 L/s. Thetotal duration of the breath, Ttot, is about 4 s. The person typicallybreathes at a rate of about 15 breaths per minute (BPM), withVentilation, Vent, about 7.5 L/s. A typical duty cycle, the ratio of Tito Ttot is about 40%.

3.7 Diagnostic System

FIG. 7 shows an example communications system 700 that may be used inmonitoring and servicing patient devices. Each patient device 720 maycomprise an RPT 4000, humidifier 5000, and patient interface 3000. FIGS.8-12 show webpages that may be displayed in accordance with aspects ofthe disclosure. FIG. 13 shows flow diagram 1300 of operations that maybe performed by patient devices disclosed herein in connection withdisclosed methods. FIG. 14 shows flow diagram 1400 for operations thatmay be performed by computing devices, such as servers, disclosedherein.

4 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is tobe understood that the technology is not limited to the particularexamples described herein, which may vary. It is also to be understoodthat the terminology used in this disclosure is for the purpose ofdescribing only the particular examples discussed herein, and is notintended to be limiting.

4.1 Treatment Systems

In one form, the present technology comprises apparatus for treating arespiratory disorder. The apparatus may comprise a flow generator orblower for supplying pressurised respiratory gas, such as air, to thepatient 1000 via an air delivery tube leading to a patient interface3000.

4.2 Therapy

In one form, the present technology comprises a method for treating arespiratory disorder comprising the step of applying positive pressureto the entrance of the airways of a patient 1000.

4.2.1 Nasal CPAP for OSA

In one form, the present technology comprises a method of treatingObstructive Sleep Apnea in a patient by applying nasal continuouspositive airway pressure to the patient.

4.3 Patient Interface 3000

A non-invasive patient interface 3000 in accordance with one aspect ofthe present technology comprises the following functional aspects: aseal-forming structure 3100, a plenum chamber 3200, a positioning andstabilising structure 3300, a vent 3400 and a connection port 3600 forconnection to air circuit 4170. In some forms a functional aspect may beprovided by one or more physical components. In some forms, one physicalcomponent may provide one or more functional aspects. In use theseal-forming structure 3100 is arranged to surround an entrance to theairways of the patient so as to facilitate the supply of air at positivepressure to the airways.

4.3.1 Seal-Forming Structure 3100

In one form of the present technology, a seal-forming structure 3100provides a sealing-forming surface, and may additionally provide acushioning function.

A seal-forming structure 3100 in accordance with the present technologymay be constructed from a soft, flexible, resilient material such assilicone.

In one form, the seal-forming structure 3100 comprises a sealing flangeand a support flange. Preferably the sealing flange comprises arelatively thin member with a thickness of less than about 1 mm, forexample about 0.25 mm to about 0.45 mm, that extends around theperimeter 3210 of the plenum chamber 3200. Support flange may berelatively thicker than the sealing flange. The support flange isdisposed between the sealing flange and the marginal edge of the plenumchamber 3200, and extends at least part of the way around the perimeter3210. The support flange is or includes a spring-like element andfunctions to support the sealing flange from buckling in use. In use thesealing flange can readily respond to system pressure in the plenumchamber 3200 acting on its underside to urge it into tight sealingengagement with the face.

In one form the seal-forming portion of the non-invasive patientinterface 3000 comprises a pair of nasal puffs, or nasal pillows, eachnasal puff or nasal pillow being constructed and arranged to form a sealwith a respective naris of the nose of a patient.

Nasal pillows in accordance with an aspect of the present technologyinclude: a frusto-cone, at least a portion of which forms a seal on anunderside of the patient's nose; a stalk, a flexible region on theunderside of the cone and connecting the cone to the stalk. In addition,the structure to which the nasal pillow of the present technology isconnected includes a flexible region adjacent the base of the stalk. Theflexible regions can act in concert to facilitate a universal jointstructure that is accommodating of relative movement—both displacementand angular—of the frusto-cone and the structure to which the nasalpillow is connected. For example, the frusto-cone may be axiallydisplaced towards the structure to which the stalk is connected.

In one form the non-invasive patient interface 3000 comprises aseal-forming portion that forms a seal in use on an upper lip region(that is, the lip superior) of the patient's face.

In one form the non-invasive patient interface 3000 comprises aseal-forming portion that forms a seal in use on a chin-region of thepatient's face.

4.3.2 Plenum Chamber 3200

Preferably the plenum chamber 3200 has a perimeter 3210 that is shapedto be complementary to the surface contour of the face of an averageperson in the region where a seal will form in use. In use, a marginaledge of the plenum chamber 3200 is positioned in close proximity to anadjacent surface of the face. Actual contact with the face is providedby the seal-forming structure 3100. Preferably the seal-formingstructure 3100 extends in use about the entire perimeter 3210 of theplenum chamber 3200.

In one form, the plenum chamber 3200 may surround and/or be in fluidcommunication with the nares of the patient where the plenum chamber3200 is a part of a nasal mask (e.g. shown in FIG. 1b ). In anotherform, the plenum chamber 3200 may surround and/or be in fluidcommunication with the nares and the mouth of the patient where theplenum chamber 3200 is a part of a full-face mask (e.g., shown in FIG.1c ). In yet another form, the plenum chamber 3200 may engage and/or bein fluid communication with one or more of the nares of the patientwhere the plenum chamber 3200 is a part of nasal pillows (e.g., shown inFIG. 29).

4.3.3 Positioning and Stabilising Structure 3300

Preferably the seal-forming structure 3100 of the patient interface 3000of the present technology is held in sealing position in use by thepositioning and stabilising structure 3300.

4.4 RPT Device 4000

An example RPT device 4000 that may be suitable for implementing aspectsof the present technology may include mechanical and pneumaticcomponents 4100, electrical components 4200 and may be programmed toexecute one or more of the control methodologies or algorithms describedthroughout this specification. The RPT device may have an externalhousing 4010, preferably formed in two parts, an upper portion 4012 ofthe external housing 4010, and a lower portion 4014 of the externalhousing 4010. In alternative forms, the external housing 4010 mayinclude one or more panel(s) 4015. Preferably the RPT device 4000comprises a chassis 4016 that supports one or more internal componentsof the RPT device 4000. In one form a pneumatic block 4020 is supportedby, or formed as part of the chassis 4016. The RPT device 4000 mayinclude a handle 4018.

The pneumatic path of the RPT device 4000 preferably comprises an inletair filter 4112, an inlet muffler 4122, a controllable pressure device4140 capable of supplying air at positive pressure (preferably a blower4142), and an outlet muffler 4124. One or more pressure sensors 4272 andflow sensors 4274 are included in the pneumatic path.

The preferred pneumatic block 4020 comprises a portion of the pneumaticpath that is located within the external housing 4010.

The RPT device 4000 preferably has an electrical power supply 4210, oneor more input devices 4220, a central controller 4230, a therapy devicecontroller 4240 and/or any of the controllers previously described, apressure device 4140, one or more protection circuits 4250, memory 4260,transducers 4270, data communication interface 4280 and one or moreoutput devices 4290. Electrical components 4200 may be mounted on asingle Printed Circuit Board Assembly (PCBA) 4202. In an alternativeform, the RPT device 4000 may include more than one PCBA 4202.

The central controller 4230 of the RPT device 4000, which may includeone or more processors, can be programmed to execute one or morealgorithm modules, preferably including a pre-processing module, atherapy engine module, a pressure control module, and further preferablya fault condition module. It may further include a vent control modulethat may be configured with one or more of the vent controlmethodologies described throughout this specification.

4.4.1 RPT Device Mechanical & Pneumatic Components 4100 4.4.1.1 AirFilter(s) 4110

A RPT device in accordance with one form of the present technology mayinclude an air filter 4110, or a plurality of air filters 4110.

In one form, an inlet air filter 4112 is located at the beginning of thepneumatic path upstream of a blower 4142. See FIG. 4 b.

In one form, an outlet air filter 4114, for example an antibacterialfilter, is located between an outlet of the pneumatic block 4020 and apatient interface 3000. See FIG. 4 b.

4.4.1.2 Muffler(s) 4120

In one form of the present technology, an inlet muffler 4122 is locatedin the pneumatic path upstream of a blower 4142. See FIG. 4 b.

In one form of the present technology, an outlet muffler 4124 is locatedin the pneumatic path between the blower 4142 and a patient interface3000. See FIG. 4 b.

4.4.1.3 Pressure Device 4140

In a preferred form of the present technology, a pressure device 4140for producing a flow of air at positive pressure is a controllableblower 4142. For example the blower may include a brushless DC motor4144 with one or more impellers housed in a volute. The blower may bepreferably capable of delivering a supply of air, for example about 120litres/minute, at a positive pressure in a range from about 4 cmH₂O toabout 20 cmH₂O, or in other forms up to about 30 cmH₂O.

The pressure device 4140 is under the control of the therapy devicecontroller 4240.

4.4.1.4 Transducer(s) 4270

In one form of the present technology, one or more transducers 4270 arelocated upstream of the pressure device 4140. The one or moretransducers 4270 are constructed and arranged to measure properties ofthe air at that point in the pneumatic path.

In one form of the present technology, one or more transducers 4270 arelocated downstream of the pressure device 4140, and upstream of the aircircuit 4170. The one or more transducers 4270 are constructed andarranged to measure properties of the air at that point in the pneumaticpath.

In one form of the present technology, one or more transducers 4270 arelocated proximate to the patient interface 3000.

4.4.1.5 Anti-Spill Back Valve 4160

In one form of the present technology, an anti-spill back valve islocated between the humidifier 5000 and the pneumatic block 4020. Theanti-spill back valve is constructed and arranged to reduce the riskthat water will flow upstream from the humidifier 5000, for example tothe motor 4144.

4.4.1.6 Air Circuit 4170

An air circuit 4170 in accordance with an aspect of the presenttechnology is constructed and arranged to allow a flow of air orbreathable gasses between the pneumatic block 4020 and the patientinterface 3000.

4.4.1.7 Oxygen Delivery

In one form of the present technology, supplemental oxygen 4180 isdelivered to a point in the pneumatic path.

In one form of the present technology, supplemental oxygen 4180 isdelivered upstream of the pneumatic block 4020.

In one form of the present technology, supplemental oxygen 4180 isdelivered to the air circuit 4170.

In one form of the present technology, supplemental oxygen 4180 isdelivered to the patient interface 3000.

4.4.2 RPT Device Electrical Components 4200 4.4.2.1 Power Supply 4210

In one form of the present technology power supply 4210 is internal ofthe external housing 4010 of the RPT device 4000. In another form of thepresent technology, power supply 4210 is external of the externalhousing 4010 of the RPT device 4000.

In one form of the present technology power supply 4210 provideselectrical power to the RPT device 4000 only. In another form of thepresent technology, power supply 4210 provides electrical power to bothRPT device 4000 and humidifier 5000. The power supply may alsooptionally provide power to any actuator, controller and/or sensors fora vent arrangement as described throughout this specification

4.4.2.2 Input Devices 4220

In one form of the present technology, a RPT device 4000 includes one ormore input devices 4220 in the form of buttons, switches or dials toallow a person to interact with the device. These may be implemented forentering settings for operation of the components of the RPT device suchas the vent arrangement. The buttons, switches or dials may be physicaldevices, or software devices accessible via a touch screen. The buttons,switches or dials may, in one form, be physically connected to theexternal housing 4010, or may, in another form, be in wirelesscommunication with a receiver that is in electrical connection to thecentral controller 4230.

In one form the input device 4220 may be constructed and arranged toallow a person to select a value and/or a menu option.

4.4.2.3 Central Controller 4230

In one form of the present technology, the central controller 4230 is adedicated electronic circuit configured to receive input signal(s) fromthe input device 4220, and to provide output signal(s) to the outputdevice 4290 and/or the therapy device controller 4240.

In one form, the central controller 4230 is an application-specificintegrated circuit. In another form, the central controller 4230comprises discrete electronic components.

In another form of the present technology, the central controller 4230is a processor suitable to control a RPT device 4000 such as an x86INTEL processor.

A processor of a central controller 4230 suitable to control a RPTdevice 4000 in accordance with another form of the present technologyincludes a processor based on ARM Cortex-M processor from ARM Holdings.For example, an STM32 series microcontroller from ST MICROELECTRONICSmay be used.

Another processor suitable to control a RPT device 4000 in accordancewith a further alternative form of the present technology includes amember selected from the family ARMS-based 32-bit RISC CPUs. Forexample, an STR9 series microcontroller from ST MICROELECTRONICS may beused.

In certain alternative forms of the present technology, a 16-bit RISCCPU may be used as the processor for the RPT device 4000. For example aprocessor from the MSP430 family of microcontrollers, manufactured byTEXAS INSTRUMENTS, may be used.

The processor is configured to receive input signal(s) from one or moretransducers 4270, and one or more input devices 4220.

The processor is configured to provide output signal(s) to one or moreof an output device 4290, a therapy device controller 4240, a datacommunication interface 4280 and humidifier controller 5250.

In some forms of the present technology, the processor of the centralcontroller 4230, or multiple such processors, is configured to implementthe one or more methodologies described herein such as the one or morealgorithms 4300 expressed as computer programs stored in anon-transitory computer readable storage medium, such as memory 4260. Insome cases, as previously discussed, such processor(s) may be integratedwith a RPT device 4000. However, in some forms of the present technologythe processor(s) may be implemented discretely from the flow generationcomponents of the RPT device 4000, such as for purpose of performing anyof the methodologies described herein without directly controllingdelivery of a respiratory treatment. For example, such a processor mayperform any of the methodologies described herein for purposes ofdetermining control settings for a ventilator or other respiratoryrelated events by analysis of stored data such as from any of thesensors described herein. Similarly, such a processor may perform any ofthe methodologies described herein for purposes controlling operation ofany vent arrangement described in this specification.

4.4.2.4 Clock 4232

Preferably RPT device 4000 includes a clock 4232 that is connected toprocessor.

4.4.2.5 Therapy Device Controller 4240

In one form of the present technology, therapy device controller 4240 isa pressure control module 4330 that forms part of the algorithms 4300executed by the processor of the central controller 4230.

In one form of the present technology, therapy device controller 4240 isa dedicated motor control integrated circuit. For example, in one form aMC33035 brushless DC motor controller, manufactured by ONSEMI is used.

4.4.2.6 Protection Circuits 4250

Preferably a RPT device 4000 in accordance with the present technologycomprises one or more protection circuits 4250.

One form of protection circuit 4250 in accordance with the presenttechnology is an electrical protection circuit.

One form of protection circuit 4250 in accordance with the presenttechnology is a temperature or pressure safety circuit.

4.4.2.7 Memory 4260

In accordance with one form of the present technology the RPT device4000 includes memory 4260, preferably non-volatile memory. In someforms, memory 4260 may include battery powered static RAM. In someforms, memory 4260 may include volatile RAM.

Preferably memory 4260 is located on PCBA 4202. Memory 4260 may be inthe form of EEPROM, or NAND flash.

Additionally or alternatively, RPT device 4000 includes removable formof memory 4260, for example a memory card made in accordance with theSecure Digital (SD) standard.

In one form of the present technology, the memory 4260 acts as anon-transitory computer readable storage medium on which is storedcomputer program instructions expressing the one or more methodologiesdescribed herein, such as the one or more algorithms 4300.

4.4.2.8 Transducers 4270

Transducers may be internal of the device, or external of the RPTdevice. External transducers may be located for example on or form partof the air delivery circuit, e.g. the patient interface. Externaltransducers may be in the form of non-contact sensors such as a Dopplerradar movement sensor that transmit or transfer data to the RPT device.

4.4.2.8.1 Flow

A flow transducer 4274 in accordance with the present technology may bebased on a differential pressure transducer, for example, an SDP600Series differential pressure transducer from SENSIRION. The differentialpressure transducer is in fluid communication with the pneumaticcircuit, with one of each of the pressure transducers connected torespective first and second points in a flow restricting element.

In use, a signal representing total flow Qt from the flow transducer4274 is received by the processor.

4.4.2.8.2 Pressure

A pressure transducer 4272 in accordance with the present technology islocated in fluid communication with the pneumatic circuit. An example ofa suitable pressure transducer is a sensor from the HONEYWELL ASDXseries. An alternative suitable pressure transducer is a sensor from theNPA Series from GENERAL ELECTRIC.

In use, a signal from the pressure transducer 4272, is received by thecentral controller processor. In one form, the signal from the pressuretransducer 4272 is filtered prior to being received by the centralcontroller 4230.

4.4.2.8.3 Motor Speed

In one form of the present technology a motor speed signal 4276 isgenerated. A motor speed signal 4276 is preferably provided by therapydevice controller 4240. Motor speed may, for example, be generated by aspeed sensor, such as a Hall effect sensor.

4.4.2.9 Data Communication Systems 4280

In one preferred form of the present technology, a data communicationinterface 4280 is provided, and is connected to central controllerprocessor. Data communication interface 4280 is preferably connectableto remote external communication network 4282. Data communicationinterface 4280 is preferably connectable to local external communicationnetwork 4284. Preferably remote external communication network 4282 isconnectable to remote external device 4286. Preferably local externalcommunication network 4284 is connectable to local external device 4288.

In one form, data communication interface 4280 is part of processor ofcentral controller 4230. In another form, data communication interface4280 is an integrated circuit that is separate from the centralcontroller processor.

In one form, remote external communication network 4282 is the Internet.The data communication interface 4280 may use wired communication (e.g.via Ethernet, or optical fibre) or a wireless protocol to connect to theInternet.

In one form, local external communication network 4284 utilises one ormore communication standards, such as Bluetooth, or a consumer infraredprotocol.

In one form, remote external device 4286 is one or more computers, forexample a cluster of networked computers. In one form, remote externaldevice 4286 may be virtual computers, rather than physical computers. Ineither case, such remote external device 4286 may be accessible to anappropriately authorised person such as a clinician.

Preferably local external device 4288 is a personal computer, mobilephone, tablet or remote control.

4.4.2.10 Output devices including optional display, alarms

An output device 4290 in Accordance with the Present Technology May Takethe form of one or more of a visual, audio and haptic unit. A visualdisplay may be a Liquid Crystal Display (LCD) or Light Emitting Diode(LED) display.

4.4.2.10.1 Display Driver 4292

A display driver 4292 receives as an input the characters, symbols, orimages intended for display on the display 4294, and converts them tocommands that cause the display 4294 to display those characters,symbols, or images.

4.4.2.10.2 Display 4294

A display 4294 is configured to visually display characters, symbols, orimages in response to commands received from the display driver 4292.For example, the display 4294 may be an eight-segment display, in whichcase the display driver 4292 converts each character or symbol, such asthe figure “0”, to eight logical signals indicating whether the eightrespective segments are to be activated to display a particularcharacter or symbol.

4.5 Communication and Diagnostic System

FIG. 7 depicts an example system 700 in which aspects of the disclosuremay be implemented. This example should not be considered as limitingthe scope of the disclosure or usefulness of the features describedherein. In this example, system 700 includes server 710, patient devices720, storage systems 750, as well as computing devices 760, which in oneexample may be associated with a clinician or device support servicepersonnel. These devices may each communicate over network 4282. System700 may be scaled to any size network. For example, while only threepatient devices 720 are shown, system 700 may include any number ofpatient devices.

Each patient device 720 may include one or more devices, including RPT4000, humidifier 5000, and patient interface 3000. In addition, eachpatient device 720 may be operated at remote locations and by differentpatients. While only controller processor 4230 and memory 4260 are shownin patient device 720, each patient device may include any of thecomponents discussed above in connection with RPT 4000, humidifier 5000,and patient interface 3000. In addition, while patient devices 720 areshown as communicating directly over 4282, each patient device may alsocommunicate over network 4282 via an external computing device. Forexample, patient device 720 may communicate with a personal computerthat transmits data over network 4282.

Servers 710 may contain one or more processors 712, memory 714 and maybe incorporated with other components typically present in generalpurpose computing devices. Memory 714 of server 710 may storeinformation accessible by processor 712, including instructions 715 thatcan be executed by the processor 712. Memory 714 may also include data718 that can be retrieved, manipulated or stored by processor 712. Thememory can be of any non-transitory type capable of storing informationaccessible by the processor. The instructions 715 may includeinstructions that are directly or indirectly executed by processor 712.In that regard, the terms “instructions,” “application,” “steps” and“programs” can be used interchangeably herein. Functions, methods androutines of the instructions are explained in more detail below.

Data, such as diagnostic data 718 may be retrieved, stored or modifiedby processor 712 in accordance with the instructions 715. For instance,although the subject matter described herein is not limited by anyparticular data structure, the data can be stored in computer registers,in a relational database as a table having many different fields andrecords, or XML documents. Diagnostic data 718 may also be anyinformation sufficient to identify or calculate relevant information,such as numbers, descriptive text, proprietary codes, pointers,references to data stored in other memories such as at other networklocations. The one or more processors 712 may include conventionalprocessors, such as a CPU, or may be a hardware-based component, such asan ASIC.

Although FIG. 7 functionally illustrates the processor, memory, andother elements of server 710, computing device 760 and patient devices720 as each being within one block, the various components of eachdevice may be stored within the different physical housings. Forexample, memory 714 may be a hard drive or other storage media locatedin a housing different from that of servers 710. Similarly, the storagesystem 750 may be part of, or be housed together with, one or more ofthe servers 710. Also, processor 712 may include a plurality ofprocessors, some or all of which are located in a housing different fromthat of servers 710. Accordingly, references to a processor, computer,computing device, or memory will be understood to include references toa collection of processors, computers, computing devices, or memoriesthat may or may not operate in parallel. Although some functions aredescribed herein as taking place on a single computing device having asingle processor, various aspects of the disclosure may be implementedby a plurality of computing devices communicating information with oneanother, such as by communicating over network 4282.

In many instances, it is preferable for patient devices 720 tocommunicate with network 4282 using wireless communication. However,network 4282 and intervening nodes described herein can beinterconnected using various protocols and systems, such that thenetwork can be part of the Internet, World Wide Web, specific intranets,wide area networks, local networks, or cell phone networks. The networkcan utilize standard communications protocols, such as Ethernet, Wi-Fi,HTTP and Bluetooth, protocols that are proprietary to one or morecompanies, and various combinations of the foregoing. Although certainadvantages are obtained when information is transmitted or received asnoted above, other aspects of the subject matter described herein arenot limited to any particular manner of transmission of information.

Servers 710 may include one or more communication servers that arecapable of communicating with storage system 750, computing device 760,and patient devices 720 via network 4282. As will be described ingreater detail below, servers 710 may receive diagnostic data 728 fromthe patient devices 720 over network 4282. In response to the receiveddiagnostic data 728, server 710 may also transmit service data 716 topatient devices 720.

Computing device 760 may be configured similarly to the servers 710,with one or more processors 762, memory 764 and instructions asdescribed above. Each computing device may be a personal computingdevice intended for use by a clinician or a device support servicepersonnel and have all of the components normally used in connectionwith a personal computing device such as a central processing unit(CPU), memory (e.g., RAM and internal hard drives) storing data andinstructions, a display such as a display 766 (e.g., a monitor having ascreen, a touch-screen, a projector, a television, or other device thatis operable to display information), and user input device 768 (e.g., amouse, keyboard, touch-screen or microphone).

A portion of the data transferred over network 4282 in accordance withaspects of the disclosure will include confidential patient information.Accordingly, system 700 may implement security measures so as to preventunauthorized access to transmitted data. In one aspect, the connectionbetween devices of system 700 may take the form of a VPN connection. Inaddition, data transmission may be based on secure socket layer (SSL)protocols. Transmitted data over network 4282 may also be encryptedusing a private key infrastructure. While aspects of the system belowprovide for data to be presented over one or more webpages, thesewebpages may be presented in connection with a protected network, sothat the webpages may only be accessible to authorized computing devicesand users.

4.6 Example Methods

As discussed above, each patient devices 720 shown in FIG. 7 may includeone or more devices, including RPT 4000, humidifier 5000, and patientinterface 3000. In performing the operations described herein, patientdevices 720 may implement instruction sets 726, which may includesoftware or firmware. As discussed above in connection with FIG. 4c ,RPT 4000 may include multiple controllers, such as humidity controller5290 and therapy device controller 4240, as well as other hardwarecomponents. During operation of patient devices 720, a fault may occurin connection with one or more components. As set forth in the systemsand methods described herein, these faults may be identified, and oftenserviced, remotely. The disclosed system allows service personnel toreceive real-time notifications and diagnostic data relating to patientdevices 720, so that potential problems may be identified even before apatient reports a problem with his or her patient device 720. If aproblem is reported by a patient, the disclosed system provides theservice personnel with visible indications of the fault, such as throughthe display of error icons and warning messages on a webpage or on apatient device dashboard, and provides a related report of detailed datarelating to operation patient device. In this way, the service personnelmay quickly determine whether the patient's reported problem is devicerelated or not.

Each patient device 720 may generate and store diagnostic data 728.Diagnostic data 728 may include any data related to the operation ofpatient device 720, including data relating to faults that have occurredor are likely to occur. In one aspect, instruction sets 726 may includeinstructions to perform comprehensive checks of patient device 720 inorder to determine whether the various components of patient device 720are operating correctly. For example, a comprehensive check may entailchecking the power supply, the air pressure being provided over patientinterface 3000, as well as the temperature of one or more components ofpatient device 720.

In accordance with one aspect, faults may be categorized based on thecomponents and operations that are effected, such as categorizing afault as relating to humidification, the heated tube, the power supply,the blower, or the like. In one example, a particular fault may becategorized based on whether it requires a patient to stop using thedevice. In particular, patient device 720 may determine whether thedetected fault is of a category that would require the patient to stopusing the device, and, if so, terminating treatment to the patient.Patient device 720 may also display an error message to the patient. Theerror message may describe the fault that has occurred or is likely tooccur.

Diagnostic data 728 is not limited to the identification of specificfaults in the patient device but may also relate to the generaloperation and use of the device. In particular, patient device 720 maygenerate a log of a patient's usage of patient device 720, includingidentifying the time periods of use, the air pressure provided duringuse, air leaks that occurred during use, as well as therapeutic settingsthat have been used during treatment. These therapeutic settings mayinclude various climate controls that can be set for automatic or manualadjustment. For example, a user may set the humidity, temperature, andexpiratory pressure levels of the patient device 720. The patient mayalso set patient device 720 to a “smart start” and “smart stop” setting,in which patient device 720 will automatically begin treatment upon thepatient putting on patient interface 3000 and will automatically stoptreatment upon the patient taking off patient interface 3000.

Diagnostic data may also relate to a patient's condition duringtreatment. For example, diagnostic data 728 may include data that can beused to calculate a patient's apnea index, hypopnea index, andapnea-hyponea index, fault data, patient usage, leak data, therapy andcomfort settings and order device activity and fault logs. Ambientconditions for patient device 720 may also be collected and stored asdiagnostic data. For example, sensors in the patient device may be usedto collect data related to the temperature and humidity of the patientdevice's surroundings. Such additional data can be collected to assistin diagnosing the reported problem in a more holistic way, as itpresents a more complete picture of the environment within which themonitored device operates. For example, if a patient reports that thetreatment starts or stops unexpectedly, information about high leak andabout the fact that the “smart start/stop” function of the pressuretherapy device was enabled, may explain the problem. Thus, solvingpatient problem is about much more than just identifying whether thereis a hardware fault in the device. The reported issue may not be aproblem at all and the may just be a perceived problem on the part ofthe patient.

In one example, diagnostic data 728 may be collected and presented as alog of events or operations that have been performed by patient device720. The log may identify instances when a fault has occurred, includingidentifying the particular component or components for which a fault hasoccurred or is likely to occur. Details on how operational parameterscan be used as an indication of a likely fault in various components ofa pressure treatment device are described in the published PCTapplication WO 2000027457. The log may comprise a list of events andoperations, as well as the date and time that each event occurred.

In accordance with one aspect, patient device 720 may transmit collecteddiagnostic data 728 to one or more external devices, such as servers 710and computing device 760. The transmission of diagnostic data 728 mayoccur at a regular interval, such as once a day or once a week, or maybe based on the occurrence of a predetermined triggering event. One suchtriggering event may be the occurrence of a fault, so that diagnosticdata 728 is transmitted as soon as a fault is detected. In addition todata relating directly to the fault, patient device may also transmitother diagnostic data 728, including therapeutic treatment informationand device settings.

The triggering event may also be based on a predetermined time periodafter which the patient has stopped using patient device 720. Forexample, instruction set 726 may indicate that diagnostic data 728should be transmitted one hour after a patient has stopped using patientdevice 720. In this example, if the patient stops using patient device720, but then resumes using it within one hour, diagnostic data 728 willnot be sent. Instead, patient device 720 will wait until the patient'suse of patient device 720 has stopped for the designated time period ofone hour before sending diagnostic data 728. By waiting a predeterminedtime period before sending diagnostic data 728, instruction set 726 mayprevent unnecessary transmissions of usage data that are due to briefinterruptions to treatment, such as when the patient adjusts or brieflyremoves patient interface 3000. The predetermined time period used totrigger the transmission of diagnostic data 728 may be configurable forthe particular instruction set 726 being implemented by a specificpatient device.

In another example, instruction set 726 may designate a triggering eventbased on the amount of time that a patient has received treatment withpatient device 720. This time period may also be configurable within theinstruction set 726 so as to balance between limiting the amount of datathat is transferred over network 4282 and achieving timeliness ofdiagnostic data. Instruction set 726 may also cause patient device 720to transmit diagnostic data 728 in the event that no treatment hasoccurred over a predetermined time period. For example, patient device720 may transmit diagnostic data 728 to server 710 indicating thatpatient device 720 has not been used in a predetermined number of hours,such as twenty-four hours.

Upon receiving diagnostic data 728 from patient device 720, server 710may store the received data as diagnostic data 718. The storeddiagnostic data at server 710 may be accessed by computing device 760,so that a user of computing device 760, such as service personnel, maymonitor the condition of each patient device. Accordingly, diagnosticdata 718 may be stored at server 710 in a manner that associates thediagnostic data 718 with a particular patient device 720 and aparticular patient. In this way, service personnel may easily detect anyissues with a particular patient device 720.

Diagnostic/fault data 728 stored at patient devices 720 may also beprovided on demand to allow for immediate review. For example, immediatereview of diagnostic data 728 may be needed if the user of patientdevice 720 calls service personnel due to a problem with the operationof patient device 720. In this instance, the service personnel may usecomputing device 760 to request for immediate transmittal of particulardiagnostic data from patient device 720, such as all diagnostic data 728that was collected over a particular time period, including anydiagnostic data 728 relating to faults that have been detected orreported by the user.

In one aspect, servers 710 may include different types of servers,including communication servers and web servers. In this example,computing device 760 may make a request for diagnostic data 728 to a webserver, which in turn transmits the request to a communication server.The communication server may then request and receive diagnostic data728 from patient device 720. In response to the request, patient device720 may transmit diagnostic data 728 as a log of operations and faults.The received log may then be transmitted from the web server to thecommunication server, where it can be accessed by computing device 760.

As set forth above, users of computing device 760, such as servicepersonnel or clinicians, may access diagnostic data 718 that has beenstored on server 710. The accessed diagnostic data 718 may be presentedto computing device 760 via a website or some other network interface.In one aspect, a user of computing device 760 may search for particulardiagnostic data 718, based on patient information.

FIG. 8 shows a screenshot 800 of webpage that may be displayed inconnection with a search of diagnostic data based on a patient's name.Screenshot 800 includes a search field 802, which may be used to input asearch query for one or more patients. The search field may be set tosearch particular attributes of patients, including the patient's name,date of birth, identification number, and the like. As shown in FIG. 8,a search has been performed for patients having the name “Doe.” As aresult, in the proposed system clinicians can now see not only a list oftheir patients, but can also see, at a glance, whether any of theirpatients has a device with a fault such as a hardware fault. The systemcan also filter the patients to only show those patients that havedevices with a fault or without a fault, depending on what is requiredby the threating clinician. In this way, the clinician couldpro-actively manage their patients that have devices with problemsrather than waiting for a phone call.

The results of the search are shown under column headings 804-812. Thename of each patient that satisfies the search query appears undercolumn heading 806. In addition, any device that the patient is usingmay be identified within the same row of the identified patient undercolumn heading 812. The identification of the patient devices inscreenshot 800 provides model numbers for each device used by thepatient, however column heading 812 may include additional informationabout the device, including identification of the device's manufacturerand the device's serial number. Under column heading 808, an icon 814may be displayed for any patient device that has experienced a fault oris likely to develop one. For example, icon 814 is displayed next to thename “John Doe,” indicating that John Doe's model S10 Newport device hasexperienced a fault. As set forth above, the determination of this faultmay be made by server 710 based on diagnostic data that has beentransmitted from John Doe's patient device 720. Icon 814 may take anynumber of forms and may change based on the type of fault that hasoccurred. For example, icon 814 may have a variable appearance dependingwhat component of the patient device has experienced a fault, whetherthe fault has caused the patient device to stop operating, and whetherthe patient has reported the fault. In this way, service personnel mayquickly identify the nature of the problem and determine what additionalactions should be considered. The service personnel may also use theappearance of icon 814, as well as any reports provided along with icon814, to determine if an issue that has been reported by a patient isdevice related or not. For example, non-device related issues mayinclude problems that arise from environmental issues or patient relatedissues.

In addition to the identification of faults, the webpage shown inscreenshot 800 may also display other diagnostic data associated witheach patient's device. For example, icons under column heading 804provide an indication of whether a patient's device is currentlyconnected to the network. In particular, icon 816 indicates that JohnDoe's device is currently connected to the network, while icon 818indicates that Robert Doe's device is not currently connected to thenetwork. The dates listed under column heading 810 indicate the date onwhich the patient last used the patient device. In accordance with oneaspect, the user of computing device 760 may customize the webpagedisplay shown in FIG. 8, so as to display additional information foreach patient device.

As shown in screenshot 900 of FIG. 9, the webpage may provide additionaldiagnostic data for particular patient devices via a popup window. Forexample, pop-up window 902 appears when the user moves cursor 904 overicon 814. A pop-up window may identify the specific patient device forwhich the fault has been detected, as well as additional informationregarding the patient. For example, pop-window 902 identifies thepatient, John Doe, by patient ID, 987-654-321, and identifies thepatient device by a serial number, 123456789. Pop-window 902 may alsodisplay information regarding the fault that has been detected for apatient device. In particular, warning icon 906 indicates that a faulthas occurred in connection with the blower of device 123456789, whilecheck icon 908 indicates that no fault has been detected in connectionwith the device's power supply. In accordance with one aspect, the usermay select warning icon 906 in order to receive additional detailsregarding the detected fault, including the specific data indicating thefault, the date and time the fault was first detected, the currentsetting of the patient device, etc. It should be noted that faults couldbe associated with any component, sub-system of functional area and thediscussed examples such as a blower (flow generator) and power supplyunits are only examples to illustrate the system capability.

FIG. 10 shows another manner in which diagnostic data may be displayedto a user. As seen in screenshot 1000, the webpage may displaydiagnostic data in connection with a list of devices, rather than a listof patients. In particular, the patient device information may bepresented without any specific identification of the patient, so as tomaintain patient privacy with respect to service personnel. For example,diagnostic data for patient devices may be accessed based on a deviceidentifier, such as a serial number. Under column 1002, specific patientdevices may be listed by their serial numbers, with any faultindications being provided under column 1004. Additional diagnostic datamay be shown in other columns. For example, the graphics shown undercolumn heading 1006 indicate usage of each patient device over the lastten days. In particular, each usage icon 1010-1018 indicates the extentto which patient device 987654321 was used over the course of aparticular day. A blank usage icon 1010 indicates that patient device987654321 was not used on May 1^(st). In contrast, usage icon 1012indicates that the patient used the patient device for at least somepredetermined amount of time, such as 6 hours, on May 6^(th). Thepartially shaded usage icon 1014 indicates that the patient device wasused on May 2^(nd), however the device was not used for thepredetermined amount of time. Usage icons 1010-1018 may also indicatethe manner in which the patient device was used. For example, the “L”shown in usage icon 1016 may indicate that air leak was detected duringthe patient's treatment on May 4^(th). In addition, the “M” shown inicon 1018 may designate that the device is currently being monitored orthat diagnostic data has not yet been received for that day. Just asdescribed above in connection with icon 814 of FIG. 9, a user may obtainadditional information in connection with the fault indicated by icon1020 by moving a cursor over or selecting icon 1020. In one aspect, theuser may select one of the usage icons 1010-1018 in order to receive alog of diagnostic data for patient device 987654321 in connection with aparticular day, as well as diagnostic data relating to the settings ofone or more patient device components at the time the fault occurred.For example, the diagnostic data may identify whether automatic climatecontrol settings were activated at the time of the fault or humiditylevel setting of the patient device at the time of the fault. The logmay include all operations and faults that occurred over a designatedtime period.

In accordance with one aspect, a patient's home care provider (HCP) orthe associated service personnel may use system 700 of FIG. 7 totroubleshoot a particular patient device 720. If a patient experiences aproblem with the patient device 7720, the HCP may use computing device760 to access diagnostic data 718 stored on server 710 for a particularpatient device 720. Upon entering identifying information, such as aserial number, for patient device 720, server 710 may provide computingdevice 760 with a troubleshooting webpage, such as the webpage shown inscreenshot 1100 of FIG. 11. This webpage may clearly display a messageindicating whether a fault has been detected for the selected device.For example, the webpage of screenshot 1100 displays fault message 1102,which indicates that a fault has occurred. This message may indicate thenature of the fault, as well as provide instructions as to how the faultmay be addressed. In particular, returning to FIG. 7, server 710 maydetermine if the detected fault may be addressed remotely. If so, thefault message may provide a phone number or webpage link to be used inseeking assistance with the fault. Alternatively, if it is determinedthat the fault cannot be addressed remotely, the message may indicatethat the patient should bring the patient device into a service centerfor the fault to be address. If the diagnostic data 718 stored at server710 does not indicate that a fault has occurred, a message may beprovided on the webpage stating that no fault has been detected.Determining whether a fault may be addressed remotely may be based, atleast in part, on whether diagnostic data 718 indicates that the faultfor patient device 720 is based on a particular form of hardwarefailure, as some faults that are based on hardware failure will need tobe addressed at a service center. In these instances, troubleshootingmay end immediately, and the patient may be instructed to take thepatient device in for servicing.

Alternatively, some hardware problems, such as mask fit, may also beaddressed remotely by providing instructions to the HCP or patient overthe troubleshooting webpage. In addition, if the fault is based oninappropriate patient device settings, or if the fault is based on thepatient device's software or firmware, the fault may be addressedremotely by server 710. For example, a fault in the software of patientdevice 720 may be addressed by an update to instruction set 726 beingtransmitted to patient device 720. Accordingly, server 710 may performtroubleshooting by transmitting an update of instruction set 726 topatient device 720 over network 4282.

In addition to fault message 1102, the troubleshooting webpage shown inFIG. 11 may display various information about patient device 720,including the device's model number and serial number. Thetroubleshooting webpage may also display the device's current settings,such as expiratory pressure relief, smart start/stop, climate controloptions, humidification settings, heated tube temperature settings, andthe like. The troubleshooting webpage may also display environmentaldiagnostic data, such as the temperature and humidity of the patient'sroom at or near the time the fault occurred. In addition, thetroubleshooting webpage may display usage data, such as the five days ofusage icons 1104 displayed in screenshot 1100. As set forth above, thisusage data may indicate the amount of time the patient has used thepatient device, the extent to which air leaks have been detected, aswell as data relating to the patient's apnea-hypopnea index. The ambientconditions for the patient device may also be displayed on thetroubleshooting webpage. Identification of various components being usedby the patient, such as the type of humidifier 5000 and the type ofpatient interface 3000, may also be identified on the troubleshootingwebpage. This information may be used by an HCP to determine the mannerin which the fault is to be addressed. For example, a fault associatedwith an air leak may be addressed in different ways, depending on thetype of mask that is being used by the patient. As shown in FIG. 11,information may be provided on the troubleshooting webpage regarding thetype of mask being used, along with recent leak information for patientdevice 720. The mask information may be used as indicators relating tounexpected stoppage in therapy or poor mask fit and may includeidentification of the design, size, and brand of the mask being usedwith patient device 720.

Using the troubleshooting webpage, an HCP, may identify what has causedthe fault and adjust the settings of patient device 720 in order toaddress the problem. In one aspect, an HCP may adjust the patient'stherapy and the settings of patient device 720 by inputting theadjustments directly into the troubleshooting webpage. For example, anHCP may use the troubleshooting webpage in FIG. 11 to adjust thehumidity level of device 123456789 from level 5 to level 3. The alteringthe humidity level in the troubleshooting webpage may be received byserver 710 shown in FIG. 7. In turn server 710 may transmit a humidityalteration command to patient device 720. Patient device 720 may thenalter its humidity level in response to the received command.

In accordance with one aspect, server 710 may transmit diagnostic data718 to computing device 760 in the form of a diagnostic log ofoperations and faults. In one example, the user of computing device 760may request a diagnostic log from server 710 for one or more patientdevices 720. This request may specify the type of diagnostic data thatis to be included in the log. For example, user, through computingdevice 760, may request a diagnostic log for all faults that haveoccurred for a particular patient device. Alternatively, the user mayrequest a log of all diagnostic data related to a particular componentor set of components, such as humidifier 5000. In this way, the user ofcomputing device may be provided with a specific set of information thatcan be used in addressing problems that have occurred in connection withpatient device 720.

Screenshot 1200 of FIG. 12 shows an example diagnostic log that may bedisplayed on a computing device. In this example, the computing devicehas requested a log of all activities and faults that have occurred overthe last 24 hours on the patient device having Ser. No. 12/345,6789. Thedates and time identified under column heading 1204 indicate the dateand time of each fault that has occurred, while the information undercolumn heading 1206 designates whether the entry relates to an activityor a fault. As provided under column heading 1208, an error code may beidentified for each fault. This allows service personnel to identify thespecific type of fault that has occurred. In addition, each log entrymay include a description, as provided under column heading 1210. Thedescription of the log entry may identify the activity that hasoccurred, such as the user putting on or taking off the device's mask,or may provide information about a fault that has occurred.

In accordance with one aspect, the diagnostic log presented to a usermay be expanded or filtered based on user input. For example, thediagnostic log shown in FIG. 12 may be expanded to include activitiesand faults that have occurred for device 123456789 over a long period oftime, such as the last 30 days. The diagnostic log may also be filteredso that it only shows a particular type of activity or so that it onlyshows faults that have occurred on the patient device. In this way, auser may easily access the information needed in servicing a patientdevice.

In accordance with one aspect, server 710 of FIG. 7 may transmit a faultindication to computing device 760 as soon as a fault has been detectedin one of the patient devices 720. Accordingly, instead of waiting for arequest for diagnostic data, server 710 may push a notification tocomputing device 760 as soon as the diagnostic data for patient device720 indicates that a fault has occurred. This notification may occur asan SMS message, e-mail, or some other form of push notifications. Inthis way, HCPs or service personnel may be immediately notified ofproblems with patient devices 720. In one example, a push notificationwill only be provided for certain types of faults, such has faults thatmay negatively affect a patient's treatment. Accordingly, upon receivingan indication of a fault from patient device 720, server 710 maydetermine whether the identified fault is one for which a pushnotification is to be transmitted to computing device 760.

FIG. 13 is a flow diagram 1300 that may be performed by a patient deviceof the disclosed system described above. In block 1302, the patientdevice collects diagnostic data in accordance with an instruction set.As set forth above, diagnostic data may include operations and faultsthat occur in connection with the patient device, as well asidentification of settings for the patient device. While collecting thediagnostic data, patient device determine whether a triggering event hasoccurred (Block 1304). Once a triggering event has been identified, thepatient device may transmit at least a portion of the diagnostic dataover a network, such as transmitting the diagnostic data to a server(Block 1306). As set forth above, a triggering event may be based onactions performed by the patient or operations performed by the patientdevice. For example a triggering event may be based on a determinationthat the patient has stopped using the patient device for apredetermined period of time. A triggering event may also includereceiving a request for diagnostic data from an external device, such asa server. The request or trigger event may require the patient device totransmit a particular portion of the collected diagnostic data. Forexample, the patient device may transmit all diagnostic data that hasbeen collected since the last transmission.

The patient device may also determine whether service data has beenreceived (Block 1308). Service data may include information provided bya remote service in attempt to address an identified fault. For example,service data may include an update to the patient device's software orfirmware or an update to one or more of the patient device's settings.If service data has not been received, the patient device may continueto collect diagnostic data and determine whether a triggering event hasoccurred in accordance with Blocks 1302 and 1304. However, if servicedata has been received, the patient device may update itself inaccordance with the received service data (Block 1310). The update mayinclude adding new instruction sets, altering current instruction sets,or altering the settings of the patient device. The patient device maythen continue to collect diagnostic data (Block 1302) and transmitdiagnostic data (Block 1306) in accordance with the current instructionset, which may include updates instructions.

FIG. 14 shows flow diagram 1400 that may be performed by computingdevices of the disclosed system, including server 710 of system 700. InBlock 1402, a server may receive a query for diagnostic data associatedwith one or more patient devices. For example, as described above,server 710 may receive a query from computing device 760 seeking data inconnection with a particular patient device or set of patient devices.This query may seek identification of all patient devices that meet oneor more criteria provided by a user of computing device 760. Thecriteria may be based on any number of aspects or features of thepatient device, including devices that have experienced faults over somedefined time period. In this way, the user of computing device 760 maybe made aware of faults shortly after they occur, possibly even beforethe patient has noted the problem or has notified the user of theproblem. The server may access diagnostic data in response to thereceived query (Block 1404), and may determine whether a fault hasoccurred in connection with the one or more patient devices (Block1406).

The server may respond to the query by transmitting diagnostic data forone or more patient devices, including identification of any faults thathave occurred for the one or more patient devices (Block 1408). Thetransmission of diagnostic data may occur over one or more webpages,such as the webpages shown in FIGS. 8-12. As set forth above, thewebpage may identify specific faults that have occurred for one or morepatient devices, as well as potential actions that should be taken inconnection with each identified fault.

The server may then receive a request for service data to be transmittedto one or more patient devices (Block 1410). The transmitted servicedata may take the form of a command to adjust to one or more devicesettings or updates to the patient device instruction set. For example,in addressing an identified fault of condensation in the conduit of apatient device, the user of computing device 760 may select specificsetting changes to be transmitted as service data to the patient device,so as to adjust the level of humidification being provided by thehumidifier of the patient device. Upon receiving the request of Block1410, the server may access or otherwise generate service data (Block1412) and transmit the service data to the patient devices identified inthe received request (Block 1414). The server may also determine if thetransmission of the service was successful (Block 1416). For example,the server may receive from each patient device either an errornotification or a message that the service data was successfullyimplemented. If an error occurred in the transmission of the servicedata, the server may transmit the service data again for each patientdevice for which the error occurred (Block 1414). However, if thetransmission is successful, the server may revise the stored diagnosticdata to indicate that the one or more patient devices have implementedthe transmitted service data (Block 1418).

While the operations set forth in FIGS. 13 and 14 may each be performedby a single device, the operations may alternatively be performed bymore than one device. For example, a patient device may communicate witha personal computer over a wireless network, so that the personalcomputer may perform one or more of the operations described above. Theserver referenced in connection with FIGS. 14 and 9 may also include aplurality of servers, with each server performing one or more of theoperations described above. Various operations may be added or removedfrom flow diagrams 1300 and 1400. For example, a system in accordancewith the current disclosure may perform the methods associated with flowdiagram 1400 without performing the procedures described in Block 1412to Block 1418. In addition, various operations need not be performed inthe same order as set forth in flow diagrams 1300 and 1400.

4.7 Glossary

In certain forms of the present technology, one or more of the followingdefinitions may apply. In other forms of the present technology,alternative definitions may apply.

4.7.1 General

Air: Air will be taken to include breathable gases, for example air withsupplemental oxygen.

Continuous Positive Airway Pressure (CPAP): CPAP treatment will be takento mean the application of a supply of air or breathable gas to theentrance to the airways at a pressure that is continuously positive withrespect to atmosphere, and preferably approximately constant through arespiratory cycle of a patient. In some forms, the pressure at theentrance to the airways will vary by a few centimeters of water within asingle respiratory cycle, for example being higher during inhalation andlower during exhalation. In some forms, the pressure at the entrance tothe airways will be slightly higher during exhalation, and slightlylower during inhalation. In some forms, the pressure will vary betweendifferent respiratory cycles of the patient, for example being increasedin response to detection of indications of partial upper airwayobstruction, and decreased in the absence of indications of partialupper airway obstruction.

4.7.2 Materials

Silicone or Silicone Elastomer: A synthetic rubber. In thisspecification, a reference to silicone is a reference to liquid siliconerubber (LSR) or a compression moulded silicone rubber (CMSR). One formof commercially available LSR is SILASTIC (included in the range ofproducts sold under this trademark), manufactured by Dow Corning.Another manufacturer of LSR is Wacker. Unless otherwise specified to thecontrary, a preferred form of LSR has a Shore A (or Type A) indentationhardness in the range of about 35 to about 45 as measured using ASTMD2240.

Polycarbonate: a typically transparent thermoplastic polymer ofBisphenol-A Carbonate.

4.7.3 Aspects of a Patient Interface

Anti-asphyxia valve (AAV): The component or sub-assembly of a masksystem that, by opening to atmosphere in a failsafe manner, reduces therisk of excessive CO₂ rebreathing by a patient.

Elbow: A conduit that directs an axis of flow of air to change directionthrough an angle. In one form, the angle may be approximately 90degrees. In another form, the angle may be less than 90 degrees. Theconduit may have an approximately circular cross-section. In anotherform the conduit may have an oval or rectangular cross-section.

Frame: Frame will be taken to mean a mask structure that bears the loadof tension between two or more points of connection with a headgear. Amask frame may be a non-airtight load bearing structure in the mask.However, some forms of mask frame may also be air-tight.

Headgear: Headgear will be taken to mean a form of positioning andstabilizing structure designed for use on a head. Preferably theheadgear comprises a collection of one or more struts, ties andstiffeners configured to locate and retain a patient interface inposition on a patient's face for delivery of respiratory therapy. Someties are formed of a soft, flexible, elastic material such as alaminated composite of foam and fabric.

Membrane: Membrane will be taken to mean a typically thin element thathas, preferably, substantially no resistance to bending, but hasresistance to being stretched.

Plenum chamber: a patient interface plenum chamber will be taken to meana portion of a patient interface having walls enclosing a volume ofspace, such as for a full-face mask (e.g., nose and mouth mask), a nasalmask or a nasal pillow, the volume having air therein pressurised aboveatmospheric pressure in use by the patient. A shell may form part of thewalls of a patient interface plenum chamber. In one form, a region ofthe patient's face abuts one of the walls of the plenum chamber, such asvia a cushion or seal.

Seal: The noun form (“a seal”) will be taken to mean a structure orbarrier that intentionally resists the flow of air through the interfaceof two surfaces. The verb form (“to seal”) will be taken to mean toresist a flow of air.

Shell: A shell will preferably be taken to mean a curved structurehaving bending, tensile and compressive stiffness, for example, aportion of a mask that forms a curved structural wall of the mask.Preferably, compared to its overall dimensions it is relatively thin. Insome forms, a shell may be faceted. Preferably such walls are airtight,although in some forms they may not be airtight.

Stiffener: A stiffener will be taken to mean a structural componentdesigned to increase the bending resistance of another component in atleast one direction.

Strut: A strut will be taken to be a structural component designed toincrease the compression resistance of another component in at least onedirection.

Swivel: (noun) A subassembly of components configured to rotate about acommon axis, preferably independently, preferably under low torque. Inone form, the swivel may be constructed to rotate through an angle of atleast 360 degrees. In another form, the swivel may be constructed torotate through an angle less than 360 degrees. When used in the contextof an air delivery conduit, the sub-assembly of components preferablycomprises a matched pair of cylindrical conduits. Preferably there islittle or no leak flow of air from the swivel in use.

Tie: A tie will be taken to be a structural component designed to resisttension.

Vent: (noun) the structure that allows a deliberate controlled rate leakof air from an interior of the mask, or conduit to ambient air, to allowwashout of exhaled carbon dioxide (CO₂) and supply of oxygen (O₂).

4.8 Other Remarks

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in the Patent and TrademarkOffice patent file or records, but otherwise reserves all copyrightrights whatsoever.

Unless the context clearly dictates otherwise and where a range ofvalues is provided, it is understood that each intervening value, to thetenth of the unit of the lower limit, between the upper and lower limitof that range, and any other stated or intervening value in that statedrange is encompassed within the technology. The upper and lower limitsof these intervening ranges, which may be independently included in theintervening ranges, are also encompassed within the technology, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the technology.

Furthermore, where a value or values are stated herein as beingimplemented as part of the technology, it is understood that such valuesmay be approximated, unless otherwise stated, and such values may beutilized to any suitable significant digit to the extent that apractical technical implementation may permit or require it.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this technology belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present technology, a limitednumber of the exemplary methods and materials are described herein.

When a particular material is identified as being preferably used toconstruct a component, obvious alternative materials with similarproperties may be used as a substitute. Furthermore, unless specified tothe contrary, any and all components herein described are understood tobe capable of being manufactured and, as such, may be manufacturedtogether or separately.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include their plural equivalents,unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated by reference todisclose and describe the methods and/or materials which are the subjectof those publications. The publications discussed herein are providedsolely for their disclosure prior to the filing date of the presentapplication. Nothing herein is to be construed as an admission that thepresent technology is not entitled to antedate such publication byvirtue of prior invention. Further, the dates of publication providedmay be different from the actual publication dates, which may need to beindependently confirmed.

Moreover, in interpreting the disclosure, all terms should beinterpreted in the broadest reasonable manner consistent with thecontext. In particular, the terms “comprises” and “comprising” should beinterpreted as referring to elements, components, or steps in anon-exclusive manner, indicating that the referenced elements,components, or steps may be present, or utilized, or combined with otherelements, components, or steps that are not expressly referenced.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

Although the technology herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thetechnology. In some instances, the terminology and symbols may implyspecific details that are not required to practice the technology. Forexample, although the terms “first” and “second” may be used, unlessotherwise specified, they are not intended to indicate any order but maybe utilised to distinguish between distinct elements. Furthermore,although process steps in the methodologies may be described orillustrated in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be madeto the illustrative embodiments and that other arrangements may bedevised without departing from the spirit and scope of the technology.

LIST OF REFENCE NUMBERS

-   system 700-   server 710-   processor 712-   memory 714-   instruction 715-   service data 716-   diagnostic data 718-   patient device 720-   instruction set 726-   diagnostic data 728-   storage system 750-   computing device 760-   processor 762-   memory 764-   display 766-   user input device 768-   screenshot 800-   search field 802-   column heading 804-812-   icons 814-818-   screenshot 900-   window 902-   cursor 904-   warning icon 906-   check icon 908-   patient 1000-   screenshot 1000-   column 1002-   column 1004-   column heading 1006-   blank usage icon 1010-   icons 1012-1020-   screenshot 1100-   fault message 1102-   usage icon 1104-   screenshot 1200-   column headings 1204-1210-   patient interface 3000-   seal-forming structure 3100-   plenum chamber 3200-   perimeter 3210-   vent 3400-   connection port 3600-   RPT device 4000-   external housing 4010-   upper portion of external housing 4012-   lower portion of external housing 4014-   panel 4015-   chassis 4016-   handle 4018-   pneumatic block 4020-   pneumatic component 4100-   air filter 4110-   inlet air filter 4112-   outlet air filter 4114-   muffler 4120-   inlet muffler 4122-   outlet muffler 4124-   pressure device 4140-   controllable pressure device 4140-   blower 4142-   controllable blower 4142-   brush less DC motor 4144-   back valve 4160-   air circuit 4170-   supplemental oxygen 4180-   electrical component 4200-   RPT device electrical component 4200-   PCBA 4202-   electrical power supply 4210-   input device 4220-   central controller 4230-   clock 4232-   therapy device controller 4240-   protection circuit 4250-   memory 4260-   transducer 4270-   pressure transducer 4272-   pressure sensor 4271-   motor speed signal 4276-   data communication interface 4280-   remote external communication network 4282-   local external communication network 4284-   remote external device 4286-   local external device 4288-   output device 4290-   display driver 4292-   display 4294-   pressure control module 4330-   humidifier 5000-   humidifier controller 5250-   humidity controller 5290-   patient device 7720

1. A method for diagnostic monitoring of medical devices comprising:receiving, by one or more processors, diagnostic data from a patientdevice, wherein the diagnostic data identifies a presence of a fault inthe patient device; storing, by the one or more processors, thediagnostic data that has been received; identifying, by the one or moreprocessors, the presence of the fault based on a first portion of thediagnostic data; transmitting, by the one or more processors, at leastone of the first portion of the diagnostic data and an identified faultwith the patient device to a remote computing device; and transmitting,by the one or more processors, service data, identified based on atleast one of the first portion of the diagnostic data and an identifiedfault, to the patient device.
 2. The method of claim 1, furthercomprising receiving, by the one or more processors, in response totransmitting the at least one of the first portion of the diagnosticdata to the remote computing device identification of the service datato be transmitted to the patient device, wherein at least a portion ofthe service data addresses an identified fault with the patient device.3. The method of claim 1 or claim 2, wherein the patient devicecomprises a respiratory pressure therapy device.
 4. The method of anyone of claims 1 to 3, wherein the diagnostic data is received based onan occurrence of a triggering event.
 5. The method of any one of claims1-4, further comprising sending to the remote computing device dataindicating whether any patient has a device with a fault.
 6. The methodof any one of claims 1-5, wherein the diagnostic data further comprisesat least one of the following; patient's apnea, hypopnea orapnea-hypopnea index, therapeutic settings, comfort settings, faultdata, patient usage, leak data, ambient humidity data, therapy andcomfort settings, device activity, and fault logs of the patient device.7. The method of any one of claims 1-6, further comprising: receiving,by the one or more processors, an indication from the patient devicethat the service data was successfully transmitted; and updating, by theone or more processors, the diagnostic data to indicate implementationof the service data.
 8. The method of any one of claims 1-7, wherein thepresence of the fault is identified based on a component, sub-system, orfunctional area of the patient device in which the fault occurred. 9.The method of any one of claims 1-8, wherein transmitting the firstportion of diagnostic data comprises a push notification to the remotecomputing device, and wherein the push notification is transmitted basedon a determination that an identified fault is of a type for which apush notification is to be provided.
 10. The method of any one of claims1-9, wherein the service data includes a command to adjust one or moresettings of the patient device.
 11. The method of any one of claims1-10, wherein the diagnostic data identifies one or more settings of thepatient device at a time at which the fault occurred.
 12. The method ofany one of claims 1-11, wherein transmitting the identified faultcomprises providing an icon for display on the remote computing device.13. The method of claim 12, wherein the icon has a variable appearancethat varies based on a type of fault that has occurred.
 14. The methodof any one of claims 1-13, wherein transmitting the identified faultfurther comprises providing usage icons for display on the remotecomputing device, wherein the usage icons indicate an extent to whichthe patient device was used.
 15. The method of any one of claims 1-14,wherein the diagnostic data includes leak information and identificationof a type of mask being used with the patient device.
 16. The method ofany one of claims 1-15, wherein the diagnostic data is accessible by adevice identifier of the patient device.
 17. The method of any one ofclaims 1-16, wherein transmitting the identified fault further comprisesproviding for display a visible indication of whether a device relatedfault has occurred.
 18. A method for diagnostic monitoring of medicaldevices comprising: collecting, by one or more processors, diagnosticdata relating to operation of a patient device, wherein the diagnosticdata identifies a presence of a fault in connection with the patientdevice; determining, by the one or more processors, that a triggeringevent has occurred for which the diagnostic data is to be transmittedover a network; transmitting, by the one or more processors, thediagnostic data over the network; receiving, by the one or moreprocessors, service data that addresses an identified fault; andperforming, by the one or more processors, one or more operations inaccordance with the service data that has been received.
 19. The methodof claim 18, wherein the patient device comprises a respiratory pressuretherapy device.
 20. The method of claim 18 or 19, wherein the triggeringevent is based on one or more conditions being met before the diagnosticdata is transmitted.
 21. The method of any one of claims 18-20, whereinthe triggering event is based on a patient having finished using thepatient device for a predetermined period of time or on a schedule forwhich diagnostic data is to be transmitted.
 22. The method of any one ofclaims 18-21, wherein the service data comprises a first portion and asecond portion, both portions being associated with different componentsof the patient device.
 23. The method of any one of claims 18-22,further comprising sending to a remote computing device data indicatingwhether any patient has a device with a fault.
 24. The method of any oneof claims 18-23, wherein at least a portion of the diagnostic datarelates to at least one of the following: a patient's apnea index,hypopnea index, apnea-hypopnea index, fault data, patient usage, leakdata, ambient humidity data, therapy and comfort settings and orderdevice activity and fault logs.
 25. A system for diagnostic monitoringof medical devices comprising one or more computing devices, the one ormore computing devices being configured to: receive diagnostic data froma plurality of patient device, wherein the diagnostic data identifies apresence of a fault in at least one of the plurality of patient devices;store the diagnostic data; identify the presence of the fault in a firstpatient device, based on the first portion of the diagnostic data;transmit at least one of the first portion of the diagnostic data andthe identified fault; and transmit service data, identified based on thefirst portion of the diagnostic data or an identified fault, to thefirst patient device.
 26. The system of claim 25, wherein the system isconfigured to transmit the first portion of the diagnostic data or theidentified fault, in response to the query from a remote device.
 27. Thesystem of claim 25 or claim 26, wherein the system is also configured toreceive identification of the service data to be transmitted to thefirst patient device, wherein at least a portion of the service dataaddresses an identified fault.
 28. The system of any one of claims25-27, wherein the first patient device comprises a respiratory pressuretherapy device.
 29. The system of any one of claims 25-28, wherein thediagnostic data is received based on an occurrence of a triggeringevent.
 30. The system of any one of claims 25-29, wherein the diagnosticdata comprises at least one of the following: a patient's apnea index,hypopnea index, apnea-hypopnea index, faults data, patient usage, leakdata, ambient humidity data, therapy and comfort settings and orderdevice activity and fault logs.
 31. The system of any one of claims25-30, wherein the one or more computing devices are further configuredto: receive an indication from the first patient device that the servicedata was successfully transmitted; and update the diagnostic data toindicate implementation of the service data by the first patient device.32. The system of any one of claims 25-31, wherein the system isconfigured to send to a remote computing device data indicating whetherany patient has a device with a fault.
 33. The system of any one ofclaims 25-32, wherein the diagnostic data comprises at least one of thefollowing: patient's apnea, hypopnea or apnea-hypopnea index,therapeutic settings, comfort settings, fault data, patient usage, leakdata, ambient humidity data, therapy and comfort settings and orderdevice activity and fault logs of the patient device.
 34. The system ofany one of claims 25-33, wherein the presence of the fault is identifiedin a component of the first patient device, a sub-system, or afunctional area.
 35. The system of any one of claims 25-34, whereintransmitting the first portion of diagnostic data comprises a pushnotification to a remote computing device, and wherein the pushnotification is transmitted based on a determination that an identifiedfault is of a type for which a push notification is to be provided. 36.The system of any one of claims 25-35, wherein the service data includesa command to adjust one or more settings of the first patient device.37. The system of any one of claims 25-36, wherein the diagnostic dataidentifies one or more settings of the first patient device at a time atwhich the fault occurred.
 38. The system of any one of claims 25-37,wherein transmitting the identified fault comprises providing an iconfor display on the remote computing device.
 39. The system of claim 38,wherein the icon has a variable appearance that varies based on a typeof fault that has occurred.
 40. The system of any one of claims 25-39,wherein transmitting the identified fault further comprises providingusage icons for display on the remote computing device, wherein theusage icons indicate an extent to which the first patient device wasused.
 41. The system of any one of claims 25-40, wherein the diagnosticdata includes leak information and identification of a type of maskbeing used with the patient device.
 42. The system of any one of claims25-41, wherein the diagnostic data is accessible by a device identifierof the patient device.
 43. The system of any one of claims 25-42,wherein transmitting the identified fault further comprises providingfor display a visible indication of whether a device related fault hasoccurred.